請用此 Handle URI 來引用此文件：
http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/81141完整後設資料紀錄
| DC 欄位 | 值 | 語言 |
|---|---|---|
| dc.contributor.advisor | 王治元(Chih-Yuan Wang) | |
| dc.contributor.author | Wen-Lin Chen | en |
| dc.contributor.author | 陳玟霖 | zh_TW |
| dc.date.accessioned | 2022-11-24T03:32:40Z | - |
| dc.date.available | 2021-08-31 | |
| dc.date.available | 2022-11-24T03:32:40Z | - |
| dc.date.copyright | 2021-08-31 | |
| dc.date.issued | 2021 | |
| dc.date.submitted | 2021-08-20 | |
| dc.identifier.citation | 1. Dall'Era, M., Chapter 21. Systemic Lupus Erythematosus, in CURRENT Diagnosis amp; Treatment: Rheumatology, 3e, J.B. Imboden, D.B. Hellmann, and J.H. Stone, Editors. 2013, The McGraw-Hill Companies: New York, NY. 2. Hoover, P.J. and K.H. Costenbader, Insights into the epidemiology and management of lupus nephritis from the US rheumatologist's perspective. Kidney Int, 2016. 90(3): p. 487-92. 3. Tsai, W.T., et al., Long-term outcomes in lupus patients receiving different renal replacement therapy. J Microbiol Immunol Infect, 2019. 52(4): p. 648-653. 4. Lionaki, S., C. Skalioti, and J.N. Boletis, Kidney transplantation in patients with systemic lupus erythematosus. World J Transplant, 2014. 4(3): p. 176-82. 5. LIN, W.-H., Incidence of progression from newly diagnosed systemic lupus erythematosus to end stage renal disease and all-cause mortality: a nationwide cohort study in Taiwan<Taiwn ESRD 2002-2008.pdf>. International Journal of Rheumatic Diseases, 2013. 6. Tektonidou, M.G., A. Dasgupta, and M.M. Ward, Risk of End-Stage Renal Disease in Patients With Lupus Nephritis, 1971-2015: A Systematic Review and Bayesian Meta-Analysis. Arthritis Rheumatol, 2016. 68(6): p. 1432-41. 7. Fanouriakis, A., et al., 2019 Update of the EULAR recommendations for the management of systemic lupus erythematosus. Annals of the Rheumatic Diseases, 2019. 78(6): p. 736-745. 8. Hahn, B.H., et al., American College of Rheumatology guidelines for screening, treatment, and management of lupus nephritis. Arthritis Care Res (Hoboken), 2012. 64(6): p. 797-808. 9. Chan, T.M., Lupus Nephritis: Induction Therapy. Lupus, 2005. 14(3_suppl): p. 27-32. 10. Moroni, G., et al., Changing patterns in clinical-histological presentation and renal outcome over the last five decades in a cohort of 499 patients with lupus nephritis. Ann Rheum Dis, 2018. 77(9): p. 1318-1325. 11. Stolyar, L., R.G. Lahita, and R.S. Panush, Rituximab use as induction therapy for lupus nephritis: a systematic review. Lupus, 2020. 29(8): p. 892-912. 12. Condon, M.B., et al., Prospective observational single-centre cohort study to evaluate the effectiveness of treating lupus nephritis with rituximab and mycophenolate mofetil but no oral steroids. Ann Rheum Dis, 2013. 72(8): p. 1280-6. 13. Diaz-Lagares, C., et al., Efficacy of rituximab in 164 patients with biopsy-proven lupus nephritis: pooled data from European cohorts. Autoimmun Rev, 2012. 11(5): p. 357-64. 14. Rovin, B.H., et al., Efficacy and safety of rituximab in patients with active proliferative lupus nephritis: the Lupus Nephritis Assessment with Rituximab study. Arthritis and rheumatism, 2012. 64(4): p. 1215-1226. 15. Sterne, J.A.C., et al., RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ, 2019. 366: p. l4898. 16. Sterne, J.A., et al., ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. BMJ, 2016. 355: p. i4919. 17. Gunnarsson, I., et al., Histopathologic and clinical outcome of rituximab treatment in patients with cyclophosphamide-resistant proliferative lupus nephritis. Arthritis Rheum, 2007. 56(4): p. 1263-72. 18. Davies, R.J., et al., Rituximab in the treatment of resistant lupus nephritis: therapy failure in rapidly progressive crescentic lupus nephritis. Lupus, 2013. 22(6): p. 574-82. 19. Contis, A., et al., Analysis of the effectiveness and safety of rituximab in patients with refractory lupus nephritis: a chart review. Clinical Rheumatology, 2016. 35(2): p. 517-522. 20. Pepper, R., et al., Rituximab is an effective treatment for lupus nephritis and allows a reduction in maintenance steroids. Nephrol Dial Transplant, 2009. 24(12): p. 3717-23. 21. Lateef, A., et al., Use of rituximab in the treatment of refractory systemic lupus erythematosus: Singapore experience. Lupus, 2010. 19(6): p. 765-70. 22. Sfikakis, P.P., et al., Remission of proliferative lupus nephritis following B cell depletion therapy is preceded by down-regulation of the T cell costimulatory molecule CD40 ligand: an open-label trial. Arthritis Rheum, 2005. 52(2): p. 501-13. 23. Lindholm, C., et al., Longterm clinical and immunological effects of anti-CD20 treatment in patients with refractory systemic lupus erythematosus. J Rheumatol, 2008. 35(5): p. 826-33. 24. Chavarot, N., et al., Rituximab alone as induction therapy for membranous lupus nephritis: A multicenter retrospective study. Medicine (Baltimore), 2017. 96(27): p. e7429. 25. Zhang, J., Z. Zhao, and X. Hu, Effect of Rituximab on Serum Levels of Anti-C1q and Antineutrophil Cytoplasmic Autoantibodies in Refractory Severe Lupus Nephritis. Cell Biochem Biophys, 2015. 72(1): p. 197-201. 26. Goswami, R.P., et al., Cyclophosphamide Versus Mycophenolate Versus Rituximab in Lupus Nephritis Remission Induction: A Historical Head-to-Head Comparative Study. J Clin Rheumatol, 2019. 25(1): p. 28-35. 27. Iaccarino, L., et al., Efficacy and safety of off-label use of rituximab in refractory lupus: data from the Italian Multicentre Registry. Clin Exp Rheumatol, 2015. 33(4): p. 449-56. Protocol 1. Dall'Era, M., Chapter 21. Systemic Lupus Erythematosus, in CURRENT Diagnosis amp; Treatment: Rheumatology, 3e, J.B. Imboden, D.B. Hellmann, and J.H. Stone, Editors. 2013, The McGraw-Hill Companies: New York, NY. 2. Hoover, P.J. and K.H. Costenbader, Insights into the epidemiology and management of lupus nephritis from the US rheumatologist's perspective. Kidney Int, 2016. 90(3): p. 487-92. 3. Tsai, W.T., et al., Long-term outcomes in lupus patients receiving different renal replacement therapy. J Microbiol Immunol Infect, 2019. 52(4): p. 648-653. 4. Lionaki, S., C. Skalioti, and J.N. Boletis, Kidney transplantation in patients with systemic lupus erythematosus. World J Transplant, 2014. 4(3): p. 176-82. 5. LIN, W.-H., Incidence of progression from newly diagnosed systemic lupus erythematosus to end stage renal disease and all-cause mortality: a nationwide cohort study in Taiwan <Taiwn ESRD 2002-2008.pdf>. International Journal of Rheumatic Diseases, 2013. 6. Tektonidou, M.G., A. Dasgupta, and M.M. Ward, Risk of End-Stage Renal Disease in Patients With Lupus Nephritis, 1971-2015: A Systematic Review and Bayesian Meta-Analysis. Arthritis Rheumatol, 2016. 68(6): p. 1432-41. 7. Fanouriakis, A., et al., 2019 Update of the EULAR recommendations for the management of systemic lupus erythematosus. Annals of the Rheumatic Diseases, 2019. 78(6): p. 736-745. 8. Hahn, B.H., et al., American College of Rheumatology guidelines for screening, treatment, and management of lupus nephritis. Arthritis Care Res (Hoboken), 2012. 64(6): p. 797-808. 9. Chan, T.M., Lupus Nephritis: Induction Therapy. Lupus, 2005. 14(3_suppl): p. 27-32. 10. Moroni, G., et al., Changing patterns in clinical-histological presentation and renal outcome over the last five decades in a cohort of 499 patients with lupus nephritis. Ann Rheum Dis, 2018. 77(9): p. 1318-1325. 11. Stolyar, L., R.G. Lahita, and R.S. Panush, Rituximab use as induction therapy for lupus nephritis: a systematic review. Lupus, 2020. 29(8): p. 892-912. 12. Condon, M.B., et al., Prospective observational single-centre cohort study to evaluate the effectiveness of treating lupus nephritis with rituximab and mycophenolate mofetil but no oral steroids. Ann Rheum Dis, 2013. 72(8): p. 1280-6. 13. Diaz-Lagares, C., et al., Efficacy of rituximab in 164 patients with biopsy-proven lupus nephritis: pooled data from European cohorts. Autoimmun Rev, 2012. 11(5): p. 357-64. 14. Rovin, B.H., et al., Efficacy and safety of rituximab in patients with active proliferative lupus nephritis: the Lupus Nephritis Assessment with Rituximab study. Arthritis and rheumatism, 2012. 64(4): p. 1215-1226. 15. Moher, D., et al., Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement. PLOS Medicine, 2009. 6(7): p. e1000097. 16. Sterne, J.A.C., et al., RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ, 2019. 366: p. l4898. 17. Sterne, J.A., et al., ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. BMJ, 2016. 355: p. i4919. 18. Gunnarsson, I., et al., Histopathologic and clinical outcome of rituximab treatment in patients with cyclophosphamide-resistant proliferative lupus nephritis. Arthritis Rheum, 2007. 56(4): p. 1263-72. 19. Davies, R.J., et al., Rituximab in the treatment of resistant lupus nephritis: therapy failure in rapidly progressive crescentic lupus nephritis. Lupus, 2013. 22(6): p. 574-82. 20. Contis, A., et al., Analysis of the effectiveness and safety of rituximab in patients with refractory lupus nephritis: a chart review. Clinical Rheumatology, 2016. 35(2): p. 517-522. 21. Pepper, R., et al., Rituximab is an effective treatment for lupus nephritis and allows a reduction in maintenance steroids. Nephrol Dial Transplant, 2009. 24(12): p. 3717-23. 22. Lateef, A., et al., Use of rituximab in the treatment of refractory systemic lupus erythematosus: Singapore experience. Lupus, 2010. 19(6): p. 765-70. 23. Sfikakis, P.P., et al., Remission of proliferative lupus nephritis following B cell depletion therapy is preceded by down-regulation of the T cell costimulatory molecule CD40 ligand: an open-label trial. Arthritis Rheum, 2005. 52(2): p. 501-13. 24. Lindholm, C., et al., Longterm clinical and immunological effects of anti-CD20 treatment in patients with refractory systemic lupus erythematosus. J Rheumatol, 2008. 35(5): p. 826-33. 25. Chavarot, N., et al., Rituximab alone as induction therapy for membranous lupus nephritis: A multicenter retrospective study. Medicine (Baltimore), 2017. 96(27): p. e7429. 26. Zhang, J., Z. Zhao, and X. Hu, Effect of Rituximab on Serum Levels of Anti-C1q and Antineutrophil Cytoplasmic Autoantibodies in Refractory Severe Lupus Nephritis. Cell Biochem Biophys, 2015. 72(1): p. 197-201. 27. Goswami, R.P., et al., Cyclophosphamide Versus Mycophenolate Versus Rituximab in Lupus Nephritis Remission Induction: A Historical Head-to-Head Comparative Study. J Clin Rheumatol, 2019. 25(1): p. 28-35. 28. Iaccarino, L., et al., Efficacy and safety of off-label use of rituximab in refractory lupus: data from the Italian Multicentre Registry. Clin Exp Rheumatol, 2015. 33(4): p. 449-56. 29. Karrar, S. and D.S. Cunninghame Graham, Abnormal B Cell Development in Systemic Lupus Erythematosus: What the Genetics Tell Us. Arthritis Rheumatol, 2018. 70(4): p. 496-507. 30. Fava, A. and M. Petri, Systemic lupus erythematosus: Diagnosis and clinical management. J Autoimmun, 2019. 96: p. 1-13. 31. Dall'Era, M. and D. Wofsy, Biologic therapy for systemic lupus erythematosus. Discov Med, 2010. 9(44): p. 20-3. 32. de Zubiria Salgado, A. and C. Herrera-Diaz, Lupus nephritis: an overview of recent findings. Autoimmune Dis, 2012. 2012: p. 849684. 33. Ichinose, K., et al., Comparison of complete renal response and mortality in early- and late-onset lupus nephritis: a multicenter retrospective study of a Japanese cohort. Arthritis Res Ther, 2020. 22(1): p. 175. 34. Bertsias, G.K., et al., Joint European League Against Rheumatism and European Renal Association-European Dialysis and Transplant Association (EULAR/ERA-EDTA) recommendations for the management of adult and paediatric lupus nephritis. Ann Rheum Dis, 2012. 71(11): p. 1771-82. 35. Atisha-Fregoso, Y., et al., CALIBRATE: A Phase 2 Randomized Trial of Rituximab Plus Cyclophosphamide Followed by Belimumab for the Treatment of Lupus Nephritis. Arthritis rheumatology (Hoboken, N.J.), 2020. 36. Fahd Adeeb, W.A.H.W.M.A. Lupus Nephritis: Current Updates. March 31st 2021. 37. 汪書弘 , et al., Rituximab Therapy in Chinese Patients with Lupus Nephritis. Formosan Journal of Rheumatology, 2013. 27(1): p. 41-46. 38. Terrier, B., et al., Safety and efficacy of rituximab in systemic lupus erythematosus: results from 136 patients from the French AutoImmunity and Rituximab registry. Arthritis Rheum, 2010. 62(8): p. 2458-66. 39. Zhong, Z., et al., Clinical efficacy and safety of rituximab in lupus nephritis. Drug Des Devel Ther, 2019. 13: p. 845-856. | |
| dc.identifier.uri | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/81141 | - |
| dc.description.abstract | "目的 在難治型狼瘡腎炎的患者，根據臨床治療指南建議可以使用莫須瘤 (Rituximab, RTX)治療，但在大型隨機雙盲臨床試驗和觀察性研究結果未能得出明確的結論。因此，我們將進行統合分析，以進一步了解 RTX在狼瘡腎炎患者中的效用。 研究方法 我們透過網路電子搜尋平台PubMed Embase和 Medline進行文獻搜索。搜尋範圍從2000-2020 年間，條件是比較狼瘡腎炎患者使用RTX與標準治療的差異。以收集總腎反應率 Total renal response, TR)進行分析，統計結果以 勝算比（ Odds ratio, OR 與比例 (Proportion) 表 示。所有統計分析使用 Cochrane Review Manager version 5.4 (Cochrane Library, UK) 和 MedCalc Software version 19.4 (Ostend, Belgium)。 結果 符合搜尋條件的共有135 篇。最終，符合納入排除條件的有四篇比較性研究與九篇單臂研究，共納入 663 接受或未接受RTX治療的狼瘡腎炎患者。結果顯示，免疫抑制劑加上RTX與免疫調節劑單用相比 有較高的 TR Odds ratio=1.76, 95CI, 1.11-2.81 。進一步分析，RTX加上目前的標準治療藥物 cyclophosphamide (CYC) 或 mycophenolate mofetil ( RTX使用於 CYC的加乘效應 (TR Odds ratio=2.78, 95 CI, 1.17-6.59) 優於 RTX用於 MMF (TR Odds ratio=1.86, 95 CI, 1.03-3.38)。 結論 我們的研究結果顯示，在誘導治療中將RTX加入狼瘡性腎炎的治療可能會達到臨床上顯著的腎臟反應率，特別是與單獨使用 CYC的情況相比。" | zh_TW |
| dc.description.provenance | Made available in DSpace on 2022-11-24T03:32:40Z (GMT). No. of bitstreams: 1 U0001-0908202111450000.pdf: 2915314 bytes, checksum: 67cb0cebd970e40ed07fd105fcb4f8a1 (MD5) Previous issue date: 2021 | en |
| dc.description.tableofcontents | "目錄 口試委員會審定書... I 誌謝... II 中文摘要... III ABSTRACT... V 在誘導治療中加入莫須瘤治療狼瘡腎炎患者的效益：系統性文獻回顧、統合分析與臨床試驗計畫書... 1 1. 介紹... 1 2. 材料與方法... 2 3. 結果... 3 4. 討論... 5 5. 參考資料... 6 APPENDIX A: PROTOCOL... 15 PROTOCOL SYNOPSIS... 17 TABLE OF CONTENTS... 25 1. INTRODUCTION... 28 1.1BACKGROUND... 28 1.2 RITUXIMAB... 30 1.2.1General Information... 30 1.3 RATIONAL OF THE STUDY DESIGN... 31 1.4 BENEFIT-RISK ASSESSMENT... 33 2. OBJECTIVES... 34 3. STUDY DESIGN... 35 3.1 DESCRIPTION... 35 3.2 ENDPOINTS... 36 3.2.1 Primary endpoint... 36 3.2.2 Secondary endpoint... 37 3.3 STUDY TREATMENTS... 39 3.4 DISCONTINUATION CRITERIA... 39 3.4.1 Study Drug Interruption Considerations... 39 3.4.2 Study Drug Discontinuation Considerations... 40 3.5 END OF STUDY... 42 4. STUDY POPULATION... 42 4.1 NUMBER OF PARTICIPANTS AND SELECTION... 42 4.2 INCLUSION CRITERIA... 42 4.3 EXCLUSION CRITERIA... 43 5. STUDY TREATMENT REGIMEN... 45 5.1 STUDY TREATMENT REGIMEN: MYCOPHENOLATE MOFETIL (CELLCEPT) ADDING ON RITUXIMAB... 45 5.1.1 Formulation, Packaging, and Labeling of Rituximab... 45 5.1.2 Preparation and Dosage of Rituximab... 46 5.1.3 Administration and Monitoring of Rituximab... 47 5.1.4 Storage of Rituximab... 48 5.1.5 Formulation, Packaging, and Labeling of Mycophenolate mofetil... 49 5.1.6 Preparation and Dosage of Mycophenolate mofetil (Cellcept)... 49 5.1.7 Administration and Monitoring of Mycophenolate mofetil (Cellcept)... 50 5.1.8 Storage of Mycophenolate mofetil (Cellcept)... 50 5.2 STUDY TREATMENT REGIMEN: CYCLOPHOSPHAMIDE... 50 5.2.1 Formulation, Packaging, and Labeling of Cyclophosphamide... 50 5.2.2 Preparation and Dosage of Cyclophosphamide... 50 5.2.3 Administration and Monitoring of Cyclophosphamide... 51 5.2.4 Storage of Cyclophosphamide... 52 5.3 ADDITIONAL STUDY MEDICATION: PREDNISONE... 52 6. STUDY PROCEDURES... 53 6.1 SCREENING PROCEDURES... 53 6.2 STUDY ENROLLMENT PROCEDURES... 54 6.3 TREATMENT PERIOD... 55 6.4 UNSCHEDULED VISIT... 55 6.5 LABORATORY TESTS... 55 7. ADVERSE EVENT REPORT... 56 7.1 DEFINITIONS... 56 7.1.1 Adverse Event... 56 7.1.2 Serious Adverse Event... 57 7.1.3 Adverse Events of Laboratory Abnormalities... 59 7.1.4 Adverse Events of Pregnancy... 59 7.1.5 Causality of Adverse Events for Rituximab... 59 7.1.6 Reporting Adverse Events to the Designee... 60 7.1.7 Unexpected Suspected Adverse Reaction... 60 7.1.8 Assessment of Severity... 61 8. STATISTICAL CONSIDERATION... 61 8.1 DEMOGRAPHIC OF BASELINE CHARACTERISTICS... 62 8.2 PRIMARY ANALYSIS... 63 8.3 SECONDARY ANALYSIS... 63 8.4 SAMPLE SIZE... 64 8.5 MISSING VALUES... 64 9. REFERENCE... 65 10. APPENDIX... 69 APPENDIX 1. STUDY PROCEDURE... 70 APPENDIX 2. LABORATORY TEST TABLE... 71 APPENDIX 3. AMERICAN COLLEGE OF RHEUMATOLOGY (ACR) CRITERIA FOR SLE... 72 APPENDIX 4. INTERNATIONAL SOCIETY OF NEPHROLOGY/RENAL PATHOLOGY SOCIETY (ISN/RPS) 2003 CLASSIFICATION OF LUPUS NEPHRITIS... 73 APPENDIX 5. SLE DISEASE ASSESSMENT SCALES... 74 APPENDIX 6. SLICC/ACR DAMAGE INDEX... 75 圖目錄 圖一. PRISMA 流程圖... 10 圖二. 單臂研究 -總腎反應之統合分析結果... 13 圖三. 比較性研究 -療效之統合分析結果... 14 圖四. 比較性研究 -不同 IS對比上有或無合併 RTX之間的療效差異... 14 表目錄 表一. 總結比較性研究的研究資料... 11 表二. 總結單臂研究的資料... 12" | |
| dc.language.iso | en | |
| dc.subject | 統合分析 | zh_TW |
| dc.subject | 狼瘡腎炎 | zh_TW |
| dc.subject | 誘導治療 | zh_TW |
| dc.subject | 系統性文獻回顧 | zh_TW |
| dc.subject | 莫須瘤 | zh_TW |
| dc.subject | induction therapy | en |
| dc.subject | systematic review | en |
| dc.subject | meta-analysis | en |
| dc.subject | lupus nephritis | en |
| dc.subject | rituximab | en |
| dc.title | 在誘導治療中加入莫須瘤治療狼瘡腎炎患者的效益：系統性文獻回顧、統合分析與臨床試驗計畫書 | zh_TW |
| dc.title | "The benefit of Rituximab adding on induction therapy for lupus nephritis: a systematic review, meta-analysis and clinical trial protocol" | en |
| dc.date.schoolyear | 109-2 | |
| dc.description.degree | 碩士 | |
| dc.contributor.oralexamcommittee | 邵文逸(Hsin-Tsai Liu),吳建陞(Chih-Yang Tseng) | |
| dc.subject.keyword | 狼瘡腎炎,莫須瘤,誘導治療,系統性文獻回顧,統合分析, | zh_TW |
| dc.subject.keyword | lupus nephritis,rituximab,induction therapy,systematic review,meta-analysis, | en |
| dc.relation.page | 75 | |
| dc.identifier.doi | 10.6342/NTU202102202 | |
| dc.rights.note | 同意授權(限校園內公開) | |
| dc.date.accepted | 2021-08-23 | |
| dc.contributor.author-college | 醫學院 | zh_TW |
| dc.contributor.author-dept | 臨床醫學研究所 | zh_TW |
| 顯示於系所單位： | 臨床醫學研究所 | |
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|---|---|---|---|
| U0001-0908202111450000.pdf 授權僅限NTU校內IP使用（校園外請利用VPN校外連線服務） | 2.85 MB | Adobe PDF |
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